Monday, July 15, 2024

Junshi Biosciences’ Hepatocellular Carcinoma Treatments Phase 3 Study Yields Positive Results

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Shanghai Junshi Biosciences Co., a leading biopharmaceutical company focused on innovative therapies, has announced that its phase III clinical study (the “HEPATORCH study,” NCT04723004) has met primary endpoints for progression-free survival (PFS) and overall survival (OS) in the first-line treatment of advanced hepatocellular carcinoma (HCC) using toripalimab in combination with bevacizumab. The company plans to submit a supplemental new drug application (NDA) for this indication soon.

Liver cancer is a prevalent malignancy in the digestive system, with hepatocellular carcinoma (HCC) making up about 90% of cases. According to the 2022 GLOBOCAN Report, there were 866,000 new liver cancer cases and 759,000 deaths globally. China faces a significant burden, with 368,000 new cases (42.4% of global cases) and 317,000 deaths (41.7%) in 2022.

Toripalimab and Bevacizumab Improve Outcomes in Advanced Hepatocellular Carcinoma

Most patients in China are diagnosed at an intermediate or advanced stage, leading to a median OS of about 10 months and a 5-year survival rate of around 12%. Advances in combination immunotherapies are changing treatment paradigms, offering potential for curative outcomes.

The HEPATORCH study, a multicenter, randomized, open-label, active-controlled phase 3 trial, evaluated the efficacy and safety of toripalimab combined with bevacizumab versus standard treatment with sorafenib for unresectable or metastatic HCC. Results indicated significant improvements in PFS and OS for the toripalimab-bevacizumab combination compared to sorafenib, with favorable secondary outcomes such as objective response rate and time to progression. The safety profile of toripalimab was consistent with known risks, with no new safety signals. Detailed results will be presented at an upcoming international academic conference.

Hepatocellular Carcinoma

Experts Highlight Toripalimab’s Potential to Improve Survival in Hepatocellular Carcinoma

Professor Jia FAN, an Academician of the Chinese Academy of Sciences and President of Zhongshan Hospital highlighted the study’s success, noting the potential of toripalimab combined with bevacizumab to offer new survival benefits for advanced liver cancer patients. Toripalimab, already approved in the US, is China’s first innovative biological drug to receive FDA approval, showcasing its international quality recognition. The hope is that more advanced liver cancer patients will benefit from domestically developed innovative drugs.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences emphasized the severe impact of hepatocellular carcinoma in China and reiterated the company’s commitment to patient-centric, world-class, affordable, and innovative drugs. The study underscores toripalimab’s role in immuno-oncology, significantly improving survival rates for advanced HCC patients. Junshi Biosciences aims to expedite regulatory approvals to benefit more patients.

 

Resource: BioSpace, June 12, 2024

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